TrachAlarm: A novel, low-cost accessory to automatically detect and alert caregivers to tracheostomy tube decannulation

TrachAlarm：一种新颖的低成本配件，可自动检测气管切开插管并提醒护理人员

• 批准号: 10266122
• 负责人: VINAY M NADKARNI
• 金额: $ 70.35万
• 依托单位: INNOVATIONS UNLIMITED, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-17 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266122
• 关键词: Adverse event; Agreement; Algorithms; Caregivers; Cessation of life; Clinical; Computer software; Development; Device Designs; Device Safety; Devices; Effectiveness; Electronics; Ensure; Event; Feedback; Future; Health care facility; Healthcare; Home; Hospitals; Individual; Instruction; Intelligence; Intuition; Label; Licensing; Life; Location; Magnetism; Manufacturer Name; Medical Device; Modification; Movement; Neck; Patients; Performance; Phase; Population; Positioning Attribute; Power Sources; Procedures; Production; Regulation; Respiration; Risk; Running; Safety; Sales; Sensitivity and Specificity; Shipping; Small Business Innovation Research Grant; Specificity; Sterile coverings; Stomas; Surveys; System; Target Populations; Technology; Testing; Time; Trachea; Tracheostomy Tube; Tracheostomy procedure; Tube; Update; Ventilator; Visual; Wireless Technology; cost; demographic disparity; demographics; design; engineering design; improved; innovation; innovative technologies; large scale production; light weight; magnetic field; novel; operation; prevent; prototype; sensor; socioeconomic disparity; success; usability

Tracheostomy provides a critical, life-supporting function for over 6.5 million individuals in the U.S. with over 110,000 new procedures each year. The TrachAlarm is a novel, low-cost accessory to automatically detect and alert caregivers when a tracheostomy tube is accidentally removed from a patient. It provides a low-cost, accessible solution for tracheostomy patients and caregivers by utilizing magnetic sensing and smart alarms. The system integrates magnetic sensors in the patient dressing, and an alarm unit that easily connects to a tracheostomy flange and trach-tie. When the dressing is placed on the patient’s neck, magnetic sensors automatically align (around the periphery of the stoma) with the trachea insertion location. The alarm unit includes circuitry to detect the magnetic field. If the tube is moved away from the trachea, the alarm unit moves along with it, removing the detected magnetic field, creating an audible and visual alarm for the caregiver. Significant innovations distinguish the TrachAlarm from other market technologies. First, existing sensors and alarms are only available on ventilators that may be connected, but not for patients not requiring ventilators. Second, magnetic field technology provides a low-cost, low-burden device, easy for caregivers to use. These features will greatly improve technology accessibility to wide ranging demographics and socioeconomic disparate populations. Finally, accurate and automated alarms provide a significant benefit to patients by improving safety and preventing adverse events with overall burden to caregivers reduced. Phase II will expand upon successful Phase I prototype results to launch a commercially and clinically deployable TrachAlarm. The project is strategically positioned with four main objectives over a two-year period with specific tasks and success milestones. Aim 1 will use Phase I results to optimize device components, system packaging and alarm delivery. This includes finalizing all electronic components, device form factor, and developing all system packaging, user guides, and labeling for shipping and use. This task will enhance device safety and effectiveness by extending the on-device alarm to wireless mobile alarming. All modifications and additions will be technically verified by formal test cases. Aim 2 will target algorithmic enhancements to the alarming strategy to optimize both sensitivity and specificity. While the device requires 100% sensitivity, it is critical high specificity is also achieved to ensure users respond to the alarm when it occurs. Aim 3 will transition all engineering designs to formal manufacturing and quality procedures. This will include scaling the design for large scale production, minimizing costs, supplier assessments, and assembly instructions. A pre-production run of devices using the full-scale manufacturing procedures will be tested as per all required input specifications, medical device standards, and quality regulations. Finally, Aim 4 will complete a final update to any device design or manufacturing procedures and produce first article devices. These devices will be implemented in a large- scale field usability study to determine performance, effectiveness, and safety in the target user population.

气管切开术为美国超过 650 万人提供了重要的生命支持功能。 每年 110,000 例新手术。 TrachAlarm 是一种新颖、低成本的附件，可自动检测和 当气管切开插管意外从患者体内拔出时，提醒护理人员。它提供了一种低成本、 利用磁感应和智能警报为气管切开术患者和护理人员提供易于使用的解决方案。 该系统在患者敷料中集成了磁性传感器，以及一个可轻松连接到 气管造口法兰和气管系带。当敷料放置在患者颈部时，磁传感器 自动与气管插入位置对齐（围绕造口周边）。报警单元包括 检测磁场的电路。如果导管移离气管，警报装置也会随之移动 它会消除检测到的磁场，为护理人员发出声音和视觉警报。 TrachAlarm 的显着创新使其区别于其他市场技术。一、现有传感器 警报仅适用于可能连接的呼吸机，但不适用于不需要呼吸机的患者。 其次，磁场技术提供了一种低成本、低负担的设备，易于护理人员使用。这些 这些功能将极大地提高技术对广泛的人口统计和社会经济的可及性 不同的人群。最后，准确和自动的警报为患者提供了显着的好处： 提高安全性并预防不良事件，减轻护理人员的总体负担。 第二阶段将在第一阶段原型成功结果的基础上进行扩展，以推出商业和临床 可展开的气管警报器。该项目的战略定位是在两年内实现四个主要目标 具有具体的任务和成功里程碑。目标 1 将使用第一阶段的结果来优化设备组件、系统 包装和警报传送。这包括最终确定所有电子元件、设备外形尺寸和 开发所有系统包装、用户指南以及运输和使用标签。此任务将增强设备 将设备上的警报扩展到无线移动警报，安全有效。所有修改和 添加的内容将通过正式的测试用例进行技术验证。目标 2 将针对算法增强 优化敏感性和特异性的警报策略。虽然该设备需要 100% 的灵敏度，但 还实现了极高的特异性，以确保用户在警报发生时做出响应。目标 3 将转变 所有工程设计到正式的制造和质量程序。这将包括扩展设计 大规模生产、最小化成本、供应商评估和装配说明。预生产运行 使用全面制造程序的设备将根据所有所需的输入规格进行测试， 医疗器械标准和质量法规。最后，Aim 4 将完成对任何设备设计的最终更新 或制造程序并生产首件设备。这些设备将在大型中实施 规模现场可用性研究，以确定目标用户群体的性能、有效性和安全性。